Friday, July 5, 2013

ORIENT: How to make a $300 drug cost $30,000 FDA rules giving exclusive rights to one drugmaker send prices skyward


As though double-digit increases in insurance premiums weren’t enough, how about triple-digit cost inflation for drugs? It is really simple to do, and the U.S. Senate is about to do it.
If you’re a drug manufacturer, and you’d like to make 100 times more than a person would otherwise have to pay for a drug, get Congress to expand the tremendous power of the Food and Drug Administration (FDA), perhaps already the most powerful anti-competitive force on the planet.
The proposed bill is S. 959, the Pharmaceutical Compounding Quality and Accountability Act, also known as the “FDA power-grab bill,” still another example of “never letting a crisis go to waste.”


Read more: http://www.washingtontimes.com/news/2013/jul/5/how-to-make-a-300-drug-cost-30000/#ixzz2YCk4gaww
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Washington State New Laws Relating to Pharmacy Compounding


No. 1145 Update on Pharmacy
Compounding
On May 7, Governor Jay Inslee signed into law, effective
immediately, House Bill 1800 that addresses resident and
nonresident pharmacy compounding.
The law defines “manufacture” to include the distribution
of a licensed pharmacy compounded drug product to other
state-licensed persons or commercial entities for subsequent
resale or distribution, unless a specific product item has approval of the Board. The term “manufacture” excludes:
(a) activities of a licensed pharmacy that compounds a
product on or in anticipation of an order of a licensed
practitioner for use in the course of their professional
practice to administer to patients;
(b) the practice of repackaging, by a licensed pharmacy,
commercially available medication in small, reasonable quantities for a practitioner legally authorized to
prescribe the medication for office use only;
(c) distribution of a drug product that has been compounded by a licensed pharmacy to other appropriately
licensed entities under common ownership or control of
the facility in which the compounding takes place; or
(d) delivery of finished and appropriately labeled compounded products dispensed pursuant to a valid prescription to alternate delivery locations, other than the
patient’s residence, when requested by the patient, or
the prescriber to administer to the patient, or to another
licensed pharmacy to dispense to the patient.
Furthermore, the law added that any medicinal products
that are compounded for patient administration or distribution
to a licensed practitioner for patient use or administration
must meet, at a minimum, the standards of the official United
States Pharmacopeia as it applies to nonsterile products and
sterile administered products.
The Board recently announced its intent to engage in
rulemaking. The Board will evaluate nationally recognized
pharmaceutical compounding standards as it updates and
establishes enforceable practice and quality standards for
the compounding of sterile and nonsterile preparation in all
pharmacy practice. Given the scope of the work at state and
federal levels on issues related to compounding pharmacy
business models and patient safety, the Board anticipates
clarifying this area of pharmacy practice for practitioners
in due course.
quoted from Washingon Board of Pharmacy July 2013 Newsletter

Washington Board of Pharmacy Legislative Changes for 2013


No. 1144 2013 Legislative Session
Washington State concluded its regular legislative session
on April 28, 2013, with the passage of several bills related to
the practice of pharmacy. The following is a list of those bills
passed into law and signed by Governor Jay Inslee. Complete
bill history is available by using the search function on the Bill
Information Web page of the Washington State Legislature.
Note: the following laws are effective July 28, 2013, unless
otherwise stated.
♦ HB 1182 – Chapter 71, Laws of 2013 amends RCW
69.41.030 to include pharmacists in the Legend Drug Act,
as authorized by a collaborative drug therapy agreement
with a prescriber.
♦ HB 1609 – Chapter 19, Laws of 2013 renames the
Washington State Board of Pharmacy to the Pharmacy
Quality Assurance Commission, doubles its members to
10 pharmacists, four public members, and adds a pharmacy technician.
♦ HB 1800 – Chapter 146, Laws of 2013  amends sections in Chapter 18.64 RCW. See article No. 1147 of this
Newsletter.
♦ HB 1808 – Chapter 133, Laws of 2013 adds a new section to Chapter 69.50 RCW. Creates requirements for
law enforcement notification and disposal in the event a
manager or employee of a retail store holding a pharmacy
license finds one ounce or less of marijuana inadvertently
left within the premises of the business. The law removes
the pharmacy, a Drug Enforcement Administration (DEA)
registrant, from the process.
♦ S SB 5148 – Chapter 260, Laws of 2013 adds a new chapter to Title 69 RCW Food, Drugs, Cosmetics, and Poisons.
The law allows for the donation of prescription drugs
or supplies by any health care practitioner, pharmacist,
medical facility, drug manufacturer, or drug wholesaler
to a participating pharmacy. Under certain conditions,
a participating pharmacy may redistribute the donated
prescription drugs and supplies without compensation
or expectation of compensation to another pharmacy,
pharmacist, or prescribing practitioner for use pursuant
to the program. Medications and supplies donated shall
be provided to uninsured or low income individuals at or
below 200% of the federal poverty level or to others if an
uninsured or low income person cannot be identified. A
pharmacist is responsible to ascertain that the prescription
drug is in the original and sealed tamper-evident packaging or, if opened, that it is contained within a unit-dose
packaging. Additionally, the prescription expiration date
must be more than six months after the date it was donated, the prescription must not contain any medications
recalled by the manufacturer, and the prescription drug
must meet the criteria of rules set forth by the Department of Health.
♦ SB 5149 – Chapter 270, Laws of 2013 adds a new section
to Chapter 9.9A RCW Washington Criminal Code. The
law adds 12 months to the standard sentence range when a
person is convicted of first-degree robbery of a pharmacy
and the allegation is proven beyond a reasonable doubt.
♦ SB 5267 – Chapter 215, Laws of 2013 establishes a
workgroup to develop criteria to streamline the prior
authorization process for prescription drugs, medical
procedures, and medical tests, with the goal of uniformity
and simplification. This requires the insurance commissioner to adopt rules implementing the recommendations
of the workgroup.
♦ SB 5416 – Chapter 276, Laws of 2013 amends the definition of electronic communication in Chapters 69.41 and
69.50 RCW and amends sections of the Uniform Controlled Substances Act to mirror federal law (CFR Title 21,
Parts 1300, 1304, 1306, 1311) pertaining to the electronic
submission of controlled (Schedule III through V) medications to allow for this practice similar to federal law. The
law establishes that a Schedule II controlled substance
(CS) may not be filled more than six months after the date
the prescription is issued. In addition, the law establishes
that a prescription for Schedule III through V cannot be
filled or refilled beyond six months from the issue date

or refilled more than five times, unless renewed by the

South Dakota Board of Pharmacy July 2013 Newsletter

North Carolina Board of Pharmacy Report from Compounding Working Group


Item 2262 – Continuing Update on Pharmacy
Compounding Matters
Item 2252 of the January 2013 Newsletter and Item 2259 of
the April 2013 Newsletter updated pharmacists on compounding
regulation matters. The North Carolina Board of Pharmacy’s Compounding Working Group reported its initial recommendations to
the Board in April. That report may be found here: www.ncbop.org/
PDF/CompoundingWorkGroupRecommendationsApril2013.pdf.
Many of the Compounding Working Group’s data collection
and training recommendations have already been implemented by
Board staff or are in the process of implementation. Other recommendations for rule amendments are presently under consideration
by the Board.
Legislative activity concerning pharmacy compounding continues apace at the federal level. S 959, the Pharmaceutical Compounding Quality and Accountability Act, was introduced in the
United States Senate on May 15, 2013. The bill may be found here:
http://thomas.loc.gov/cgi-bin/query/z?c113:S.959. The bill’s chief
proposal is to categorize “compounding manufacturers,” which
would be regulated primarily and exclusively by Food and Drug
Administration (FDA). A compounding manufacturer is defined
as a facility that either:
(1) compounds any sterile drug product without receiving a
prescription order for such sterile drug product prior to beginning compounding and distributes or offers to sell such
compounded product in interstate commerce; or
(2) repackages any preservative-free sterile product or pools any
such sterile drug products (with some exceptions).
Observers expect the US House of Representatives to introduce
its own legislation concerning pharmacy compounding, but no bill
had been introduced at the time of this writing.
In late May, reports again surfaced of potentially contaminated preservative-free methylprednisolone acetate injections,
this time from the Main Street Family Pharmacy in Newbern, TN.
Board staff sought and obtained a surrender of Main Street Family Pharmacy’s out-of-state pharmacy permit, and worked with
the North Carolina Department of Health and Human Services
to identify and contact clinics and patients who had received the
potentially contaminated products. Main Street Family Pharmacy
initiated a voluntary recall of all compounded sterile products. At
the time of this writing, several adverse event reports have been
collected from a handful of states. State and federal authorities are
cooperating in the investigation, and twice-weekly updates may
be found here: www.cdc.gov/hai/outbreaks/tn-pharmacy/index
.html?mobile=nocontent.
In April, the Board issued a partial summary suspension of the
pharmacy permit held by Stewart Pharmaceuticals in Fayetteville,
NC, stemming from concerns over sterility control measures.
Stewart Pharmaceuticals subsequently issued a voluntary recall of
all sterile products. More information on the recall may be found
here: www.ncbop.org/PDF/StewartRecallNotice041213.pdf.

quoted from North Carolina Board of Pharmacy July 2013 Newsletter

New Jersey Board of Pharmacy New Regulations Regarding Compounding


Compounding Sterile and Nonsterile
Preparations in Retail and Institutional
Pharmacies
The substantially modified N.J.A.C. 13:39-11 (Compounding Sterile and Non-Sterile Preparations in Retail and Institutional Pharmacies) is now in effect, and can be accessed
in the updated “Pharmacy Regulations” hyperlink at www
.njconsumeraffairs.gov/pharm/phar_rules.htm, which was
last revised on June 3, 2013. The new regulation divides the
subchapter into sterile compounding (N.J.A.C. 13:39-11.1-
24) and nonsterile compounding (N.J.A.C. 13:39-11A.1-15),
and brings New Jersey regulations into agreement with the
practice standards established by the United States Pharmacopeia General Chapter 797 (Pharmaceutical Compounding
of Sterile Preparations) and General Chapter 795 (Pharmaceutical Compounding of Nonsterile Preparations). The New
Jersey State Board of Pharmacy urges all licensees to become
familiar with the new regulation. Accordingly, in this issue the
Board Newsletter will begin a series of articles designed to
summarize critical changes in the new regulation. This issue
will cover N.J.A.C. 13:39-11.4-7 of the sterile compounding regulations, encompassing new spatial requirements and
terminology.
♦ N.J.A.C. 13:39-11.4 was recodified from the old N.J.A.C.
13:39-11.16 and amended to refer to “cleanrooms” instead
of the old term “controlled environment for compounded
sterile preparations.”
◊ 13:39-11.4(a) sets forth the physical criteria that a cleanroom must meet to minimize airborne contamination
from contacting critical sites.
◊ 13:39-11.4(b) requires that all sterile compounding
take place within the confines of a buffer area unless
it meets one of the exceptions set forth in paragraphs
(b)1 through 3.
◊ 13:39-11.4(c)(4) is amended to add that 66ºF is the ideal
temperature for a cleanroom.
◊ 13:39-11.4(d) requires a pressure indicator or air velocity meter to monitor the room for correct room pressurization or air velocity.
13:39-11.4 Cleanroom: Use, Access, Location; Temperature; Air Pressure
(a) The pharmacy shall have a designated area for
sterile preparation compounding, known as the
“cleanroom.” A cleanroom shall be physically designed and environmentally controlled to minimize
airborne contamination from contacting critical
sites. Critical sites are locations that include any
component or fluid pathway surfaces (for example,
vial septa, injection ports, beakers), openings (for
example, opened ampules, needle hubs), exposed
and at risk of direct contact with air (for example,
ambient room or HEPA-filtered), moisture (for
example, oral and mucosal secretions), or touch
contamination. A cleanroom shall include a buffer
area and an ante area. The buffer area shall contain
an ISO class 5 or better primary engineering control,
such as a laminar airflow workbench, biological
safety cabinet, compounding aseptic isolator, and/or
compounding aseptic containment isolator, unless
the buffer area has ISO class 5 or better air quality.
(b) All sterile compounding shall take place within the
confines of the buffer area, except for the following:
1. Compounding in a compounding aseptic isolator
or a compounding aseptic containment isolator
pursuant to N.J.A.C. 13:39-11.8;
2. Compounding in a laminar air flow workbench
in an institutional pharmacy pursuant to N.J.A.C.
13:39-11.10; and
3. Compounding immediate use compounded
sterile preparations in an institutional pharmacy
pursuant to N.J.A.C. 13:39-11.11.
(c) A cleanroom shall be:
1. Accessible only to designated personnel;
2. Used only for the compounding of sterile
preparations or such other tasks that require a
cleanroom;

(i) Carts shall be of stainless steel wire, nonporous
plastic, or sheet metal construction with good quality, cleanable casters to promote mobility.
(j) Refrigerators shall be within, or reasonably accessible to, the cleanroom in order to ensure the
integrity of the compounded sterile preparations,
consistent with the requirements of N.J.A.C.
13:39-11.12(b)3.
♦ N.J.A.C. 13:39-11.6 was recodified from the old N.J.A.C.
13:39-11.20 and amended to refer to “ante areas” instead
of “anterooms.”
◊ 13:39-11.6(a) was amended to require that the ante
area have appropriate environmental control devices
capable of maintaining ISO Class 8 air quality conditions for non-hazardous drug compounding activities
and ISO Class 7 air quality conditions for hazardous
drug compounding activities. The old 13:39-11.20
required only that the anteroom have an air quality of
ISO Class 7 or better, and did not differentiate between
non-hazardous and hazardous drug compounding
activities.
◊ 13:39-11.6(b)(1) was amended to require that an ante
area contain a sink with hot and cold running water
with an integrated and closed plumbing system.
◊ The old 13:39-11.20(c) (which required that a refrigerator be reasonably accessible to the anteroom) was
deleted.
13:39-11.6 Ante Area Requirements
(a) The ante area shall have appropriate environmental
control devices capable of maintaining ISO class
8 air quality conditions for non-hazardous drug
compounding activities and ISO class 7 air quality conditions for hazardous drug compounding
activities as provided in N.J.A.C. 13:39-11.4(d)2.
(b) The ante area shall contain the following equipment:
1. A sink with hot and cold running water with an
integrated and closed plumbing system;
2. Waste containers for all personal protective
equipment;
3. An eyewash station; and
4. A hazardous waste spill kit.
♦ N.J.A.C. 13:39-11.7 was recodified from the old N.J.A.C.
13:39-11.18 and amended to refer to “buffer areas” instead of  “controlled environment for compounded sterile
preparations.”
◊ 13:39-11.7(a) requires that a buffer area have appropriate environmental control devices capable of
maintaining ISO Class 7 air-quality conditions during
normal activity.
◊ 13:39-11.7(c) prohibits removal of any equipment or
other items from the buffer area, with certain exceptions. The old N.J.A.C. 13:39-11.18(b) discouraged
equipment removal but did not strictly prohibit it.


13:39-11.5(e) was amended to refer to “walls” instead
of “solid walls” and to permit walls to be constructed
of flexible materials such as heavy gauge polymer
in addition to the other materials specified in the old
N.J.A.C. 13:39-11.17(e) regulation.
◊ 13:39-11.5(f) was amended to prohibit the use of floor
drains.
◊ 13:39-11.5(g) was amended to state that ledges (such
as windowsills) should be avoided, but are not strictly
prohibited as they were in the old N.J.A.C. 13:39-
11.17(g).
◊ 13:39-11.5(j) requires that refrigerators be within, or
reasonably accessible to, cleanrooms in order to ensure
the integrity of the compounded preparations.
◊ The old N.J.A.C. 13:39-11.17(j), which required Board
approval for cleanroom construction other than that
specified in N.J.A.C. 13:39-11.17(a-i) prior to installation and use, was deleted.
13:39-11.5 Cleanroom Requirements
(a) The surfaces of ceilings, walls, floors, fixtures,
shelving, counters, and cabinets in the cleanroom
shall be smooth, impervious, free from cracks and
crevices, and nonshedding, thereby minimizing
spaces in which microorganisms and other contaminants may accumulate.
(b) Work surfaces shall be constructed of smooth,
impervious materials, such as stainless steel or
molded plastic, so that the work surfaces may be
readily cleaned and sanitized. All work surfaces
shall be resistant to damage from cleaning and
sanitizing agents.
(c) Junctures where ceilings meet walls shall be
covered, caulked, or sealed to avoid cracks and
crevices in which microorganisms and other contaminates can accumulate. All areas in ceilings
and walls where the surface has been penetrated
shall be sealed.
(d) Ceilings that consist of inlaid panels shall be impregnated with a polymer to render them impervious and hydrophobic and shall either be caulked
or weighted and clipped.
(e) Walls shall be constructed of flexible material (for
example, heavy gauge polymer), panels locked
together and sealed, or of epoxy-coated gypsum
board.
(f) Floors shall have a covering and shall be seamless or have heat-welded seams and coving to the
sidewall. There shall be no floor drains.
(g) There shall be no dust-collection overhangs (such
as ceiling utility pipes) and ledges (such as window sills) should be avoided. All sprinkler heads
shall be flush with the ceiling.
(h) Ceiling lighting fixtures shall have exterior lens
surfaces which are smooth, mounted f1ush, and
air tight (i) Carts shall be of stainless steel wire, nonporous
plastic, or sheet metal construction with good quality, cleanable casters to promote mobility.
(j) Refrigerators shall be within, or reasonably accessible to, the cleanroom in order to ensure the
integrity of the compounded sterile preparations,
consistent with the requirements of N.J.A.C.
13:39-11.12(b)3.
♦ N.J.A.C. 13:39-11.6 was recodified from the old N.J.A.C.
13:39-11.20 and amended to refer to “ante areas” instead
of “anterooms.”
◊ 13:39-11.6(a) was amended to require that the ante
area have appropriate environmental control devices
capable of maintaining ISO Class 8 air quality conditions for non-hazardous drug compounding activities
and ISO Class 7 air quality conditions for hazardous
drug compounding activities. The old 13:39-11.20
required only that the anteroom have an air quality of
ISO Class 7 or better, and did not differentiate between
non-hazardous and hazardous drug compounding
activities.
◊ 13:39-11.6(b)(1) was amended to require that an ante
area contain a sink with hot and cold running water
with an integrated and closed plumbing system.
◊ The old 13:39-11.20(c) (which required that a refrigerator be reasonably accessible to the anteroom) was
deleted.
13:39-11.6 Ante Area Requirements
(a) The ante area shall have appropriate environmental
control devices capable of maintaining ISO class
8 air quality conditions for non-hazardous drug
compounding activities and ISO class 7 air quality conditions for hazardous drug compounding
activities as provided in N.J.A.C. 13:39-11.4(d)2.
(b) The ante area shall contain the following equipment:
1. A sink with hot and cold running water with an
integrated and closed plumbing system;
2. Waste containers for all personal protective
equipment;
3. An eyewash station; and
4. A hazardous waste spill kit.
♦ N.J.A.C. 13:39-11.7 was recodified from the old N.J.A.C.
13:39-11.18 and amended to refer to “buffer areas” instead of  “controlled environment for compounded sterile
preparations.”
◊ 13:39-11.7(a) requires that a buffer area have appropriate environmental control devices capable of
maintaining ISO Class 7 air-quality conditions during
normal activity.
◊ 13:39-11.7(c) prohibits removal of any equipment or
other items from the buffer area, with certain exceptions. The old N.J.A.C. 13:39-11.18(b) discouraged
equipment removal but did not strictly prohibit it.

Minnesota Board of Pharmacy to Hire Additional Pharmacists Soon


Board to Hire Additional Pharmacists Soon
During the 2013 Legislative Session, the Board was granted
a $210,000 increase in its appropriation for the purpose of
hiring additional staff. Note that there was no need to request
for fee increases. The number of licenses issued by the Board
has increased at a greater than expected rate, so there will be
sufficient new revenue to offset the increase in spending. The
Board is awaiting final approval to create two new positions.
♦ Deputy director will be classified as a pharmacist senior,
a classification that is at the same pay grade as the pharmacy
surveyor classification, but which has different
class specifications. The deputy director will report to the
executive director and will be “second-in-command” when
it comes to the Board’s operations. The deputy will also
focus on certain aspects of the complaint and disciplinary processes
and will be assigned to work on some of
the many policy issues that currently confront the Board.
Additional education or experience working closely with
pharmacy- and drug-related laws, rules, or policy will be
preferred for this position.
♦ Pharmacy surveyor will be classified as a pharmacy surveyor.
The individual filling this position will join with the
existing pharmacy surveyors to inspect facilities; review
inspection reports submitted by out-of-state facilities that
are licensed by the Board; investigate complaints; provide
consultation to licensees, registrants, and the public; and
participate in the review of variances and policies, etc.

Creation of these positions is necessary because of the
Board’s increased workload. The number of licenses and
registrations issued by the Board has increased substantially
in recent years. Also, in response to the fungal meningitis
outbreak linked to a Massachusetts compounding pharmacy,
the legislature enacted statutes that will require much closer
scrutiny of applications for out-of-state pharmacies, drug
manufacturers, drug wholesalers, and medical gas distributors.
The Board and its staff have also been asked to work on
a variety of policy issues including synthetic designer drugs,
prescription drug abuse, regulation of methadone treatment
facilities, pharmaceutical waste, the “gray market” for pharmaceuticals, a
 complete revision of the Pharmacy Practice
Act, and better regulation of compounding, drug shortages,
and more.
Pharmacists who are interested in these positions should
regularly check the Board’s Web site for additional announcements.
The plan is to have these positions filled by late summer or early fall.

quoted from Minnesota Board of Pharmacy July 2013 Newsletter

Minnesota Board of Pharmacy Recent Disciplinary Action Including Against AlixaRX Because Personnel Compounded Sterile Products Without Proper Training


The Minnesota Board of Pharmacy took the following
disciplinary action concerning a pharmacist between the
dates of April 11, 2013 and June 19, 2013.
Hins, Dennis D., License #112063. Mr Hins erroneously
dispensed methadone to a patient. The drug actually prescribed was methotrexate. He admitted that he was not
doing quality assurance as required by Minnesota Rules
6800.3950, Subp 4. He further admitted that he had not
developed a quality assurance policy, despite having been
instructed to do so during an earlier routine inspection.
Consequently, the Board adopted a stipulation and consent
order at its May 1, 2013 meeting, which reprimanded Mr
Hins, required him to pay a civil penalty in the amount of
$2,500, and required him to complete a continuing education course focusing on error prevention.
The Board took the following disciplinary actions concerning pharmacy technicians between the dates of April 11,
2013 and June 19, 2013.
Anderson, Michelle G., Registration #702905. Ms Anderson admitted that she stole several bottles of prescription
medications from her employer. As a result, she was
charged with felony theft in December 2012. Consequently,
at its May 1, 2013 meeting, the Board adopted a stipulation and consent order for the voluntary surrender of Ms
Anderson’s registration.
Sannes, Paige M., Registration #726105. From September
2010 through December 2011, Ms Sannes had multiple
charges and convictions for alcohol-related offenses in
North Dakota and Minnesota. As a result, her North
Dakota registration as a pre-pharmacy intern was placed
on conditional status in January 2012. The North Dakota
State Board of Pharmacy revoked her registration in July
2012 for failure to submit required reports. Ms Sannes
also pleaded guilty to shoplifting in July 2012. She failed
to fully disclose her convictions when registering with
the Minnesota Board as a pharmacy technician in August
2012. Consequently, at its May 1, 2013 meeting, the Board
adopted an order that reprimanded Ms Sannes and required
her to pay a $250 civil penalty. In addition, Ms Sannes
was required to enroll in the Health Professionals Services
Program (HPSP).
The Board took the following disciplinary action concerning a pharmacy between the dates of April 11, 2013 and June
19, 2013.
AlixaRx, License #263885. Representatives of AlixaRx admitted that personnel of the pharmacy compounded sterile products without proper training and that on at least one occasion, pharmacy technicians were working without proper
supervision because the pharmacy was out of compliance with
the allowed technician-to-pharmacist ratio. Consequently,
the Board adopted an order at its May 1, 2013 meeting that
reprimanded AlixaRx and imposed a civil penalty of $5,000.

quoted from here

Thursday, July 4, 2013

Louisiana Board of Pharmacy March-June 2013 Disciplinary Action


Disciplinary Actions (13-07-436)
During its May 2013 meeting, the Board took final action in the
following matters:
Peggy Ann Robins (PTC Applicant): Denied the application for
pharmacy technician candidate registration and refused to issue the
credential.
David Wayne Spears (PST.010314): Suspended the license for two
years and stayed the execution thereof, then placed the license on
probation for two years, effective June 1, 2013, subject to certain
terms enumerated in the consent agreement, and further assessed
administrative and investigative costs; for 15 counts, including dispensing multiple prescriptions for controlled substances (CS) pursuant
to forged prescriptions.
Kristi Ann Phillips (CPT.008552): Certificate suspended for an indefinite period of time, effective March 13, 2013; for failure to submit
to medical evaluation as directed by the Board.
Kori Kiffe Wright (CPT.009060): Accepted voluntary surrender of
the credential, resulting in active suspension of the certificate for an
indefinite period of time, effective March 25, 2013.
Cortina LaShone Richardson (CPT.005255): Suspended the certificate for five years and stayed the execution of the suspension, then
placed the certificate on probation for five years, effective June 1,
2013, subject to certain terms enumerated in the consent agreement;
for five counts, including possession of a firearm while in unlawful
possession of Schedule I CS.
Kimiko Tiesha Austin (CPT.005676): Granted request for reinstatement of the previously suspended certificate, converted the suspensive
period from an indefinite term to a term of five years and stayed the
execution of the suspension, and then placed the license on probation for five years, effective May 29, 2013, subject to certain terms
enumerated in the consent agreement.
Roy Kirk Fisher (PST.018600): Granted request for reinstatement of
the previously suspended license, converted the suspensive period
from an indefinite term to a term of 10 years and stayed the execution of the suspension, and then placed the license on probation for
10 years, effective May 29, 2013, subject to certain terms enumerated
in the consent agreement.
David Collins Evans (PST.014181): Granted request for reinstatement
of the previously suspended license, converted the suspensive period
from an indefinite term to a term of 15 years and stayed the execution
of the suspension, and then placed the license on probation for 15
years, effective May 29, 2013, subject to certain terms enumerated
in the consent agreement.
Michael Thomas Savario (PST.016568): Granted request for reinstatement of the previously suspended license, converted the suspensive
period from an indefinite term to a term of 15 years and stayed the
execution of the suspension, and then placed the license on probation
for 15 years, effective May 29, 2013, subject to certain terms enumerated in the consent agreement.
Leslie Eileen Rodgers (PST.016948): Granted request for termination
of probationary period, returning the license to active and unrestricted
status, effective May 29, 2013.
Catherine Powell Kain (PST.020150): Approved application for pharmacist licensure by reciprocity, authorized issuance of pharmacist
license then immediately suspended that license for a period of time
ending May 17, 2016, and stayed the execution of the suspension, then
placed the license on probation for a period of time ending May 17,
2016, subject to certain terms enumerated in the consent agreement.

Michael Glenn Harlton (PTC Applicant): Approved application for
pharmacy technician candidate registration, authorized issuance of
the registration and then immediately suspended that registration for
five years and stayed the execution of the suspension, then placed
the registration on probation for five years, effective on the date of
issuance of the registration, subject to certain terms enumerated in
the consent agreement.
Bryant Paul Pierce, Jr (CPT.001594): Granted request for reinstatement of the expired certificate, conditioned upon the satisfaction
of certain terms identified in the consent agreement, and further,
suspended the special work permit and certificate for one year and
stayed the execution of the suspension, then placed the special work
permit and certificate on probation for one year, effective on the
date of issuance of the special work permit, subject to certain terms
enumerated in the consent agreement.
Adriel Peter Joseph (PST.017298): Granted request for reinstatement
of the previously suspended license, conditioned upon satisfaction
of certain terms identified in the consent agreement, and further,
suspended the license for three years and stayed the execution of the
suspension, then placed the license on probation for three years, effective on the date of issuance of the license, subject to certain terms
enumerated in the consent agreement.
Medisca, Inc (CDS.025126): Suspended the license for three years
and stayed the execution thereof, then placed the license on probation
for three years, effective January 10, 2013, subject to certain terms
enumerated in the consent agreement; for activities that prompted the
disciplinary action taken by the South Carolina Department of Labor,
Licensing, and Regulation – Board of Pharmacy on the distributor’s
resident permit.
Samantha Sellers Michelli (CPT.004416): Revoked the certificate,
and further, permanently prohibited any future application for reinstatement of the certificate or for any other credential issued by the
Board; for five counts, including diversion of CS from her employer
pharmacy.
Advantage Pharmacy (PHY.006676): Suspended the pharmacy permit
for 11 months and 17 days and stayed the execution of the suspension,
then placed the permit on probation for 11 months and 17 days, effective June 1, 2013, subject to certain terms enumerated in the consent
agreement; for activities that prompted the disciplinary action taken by
the Mississippi Board of Pharmacy on the pharmacy’s resident permit.
Mehrdad Hariri (PST.019770): Suspended the license for four years,
seven months, and 25 days and stayed the execution of the suspension,
then placed the license on probation for four years, seven months, and
25 days, effective June 1, 2013, subject to certain terms enumerated
in the consent agreement; for two counts, including activities which
prompted the disciplinary action taken by the Florida Board of Pharmacy on his resident pharmacist license.

Travellis Eugene Harrison, Sr (CPT.010618): Revoked the certificate, and further, permanently prohibited any future application for
reinstatement of the certificate or for any other credential issued by
the Board; for five counts, including alleged diversion of CS from his
employer pharmacy.
Chantelle Denise Williams (CPT.004794): Revoked the certificate,
and further, permanently prohibited any future application for reinstatement of the certificate or for any other credential issued by the
Board; for five counts, including alleged diversion of CS from her
employer pharmacy.
John Edward Bull (PST.010451): Accepted the voluntary surrender
of the credential, resulting in active suspension of the license for an
indefinite period of time, effective May 7, 2013.
Barry Joseph Robichaux (PST.010309): Accepted the voluntary surrender of the credential, resulting in active suspension of the license
for an indefinite period of time, effective May 10, 2013.
During the same meeting, the Board granted approval for the reinstatement of an expired license for a pharmacist and an expired certificate
for a technician, as well as conditional approval for the reinstatement
of expired credentials for two pharmacists and one technician, pending
satisfaction of certain terms enumerated in their consent agreements.
The Board also issued a letter of warning to the owner of a pharmacy
permit as well as letters of reprimand to two pharmacists and the owners of two pharmacy permits, and further, suspended the controlled
dangerous substance licenses for five physicians whose medical licenses
were suspended by the Louisiana State Board of Medical Examiners.
quoted from Louisiana Board of Pharmacy July 2013 Newsletter



Louisiana Board of Pharmacy Continues to Promulgate New Rules Regarding Compounding


Rulemaking Activities (13-07-435)
The Louisiana Board of Pharmacy published a new edition of the
Louisiana Pharmacy Law Book on April 15, 2013. The electronic version of that reference is available on the “Laws & Rules” page of the
Board’s Web site. For those who wish to purchase a printed copy of the
updated law book, a product order form is also available on that same
page of the Web site.
The Board continues to promulgate new rules as well as revisions to
current rules. The Board sends electronic Notices of Rulemaking Activity
to its clients about these activities.
♦ Regulatory Project 2013-1 ~ Compounding for Prescriber Use. The
Board voted to issue an emergency rule on January 29, 2013, that
places limits on the amount of compounding for prescriber use a
pharmacy may prepare. Since that time, the Board has been working
through the process to develop a permanent rule. During its May
29 meeting, the Board voted to reissue the same emergency rule
to give the Board more time to complete the rulemaking process
for a permanent rule.
♦ Regulatory Project 2013-2 ~ Hospital Off-Site Satellite Pharmacy.
The Board added new language to Chapter 15 of the Board’s rules,
allowing for the establishment and operation of satellite pharmacies
in hospitals, subject to the provisions contained in the new rule.
This new rule became effective on May 20, 2013.
♦ Regulatory Project 2013-3 ~ Pharmacy Technician Training
Programs. The Board published the Notice of Intent in the April
edition of the Louisiana Register and convened a public hearing
on May 30, to receive comments and testimony on the proposed
revision to the current rules.
Finally, you can monitor the progress of all regulatory proposals and
projects by visiting the “Public Library” section of the Board’s Web site,
selecting the “Public Notices” link, and then reviewing the appropriate
links for “Regulatory Proposals” and “Regulatory Projects.

Quoted from Louisiana Board of Pharmacy July 2013 Newsletter

Arizona Board of Pharmacy Discipline Action Against Pharmacists for March -May 2013


Disciplines – Licensees
Pharmacists
Castaneda, Thomas (S006020) – Probation terminated. Effective May 9, 2013.
Harris, David (S015757) – $250 fine and eight continuing
education units (CEUs) within 90 days. Effective May 10,
2013.
Jade,  Amanda (S018421) – $250 fine and eight CEUs within
90 days. Effective May 10, 2013.
Liberato, Justine (S019419) – $250 fine and eight CEUs
within 90 days. Effective May 10, 2013.
Massey, Douglas (S016067) – $250 fine and eight CEUs
within 90 days. Effective May 9, 2013.
Nguyen, Khang (S013435) – $500 fine and eightCEUs within
90 days. Effective May 10, 2013.
Peterson, James (S009155) – Probation terminated. Effective May 9, 2013.
Underhill, Stephanie (S015729) – Probation terminated.
Effective March 20, 2013.
Wamboldt, David (S013400) – Probation terminated. Effective March 20, 2013.
White, Abigail (S016280) – Five-year probation. Pharmacists
Assisting Pharmacists of Arizona (PAPA) contract. Effective
March 26, 2013.

quoted from Arizona Board of Pharmacy July 2013 Newsletter

Arizona Board of Pharmacy gets New Board Member and Not So New Compliance Officer With Knowledge of Compounding


The Board staff is pleased to report that Governor
Jan Brewer has appointed Darren Kennedy, a pharmacist employed at
Walgreens Healthcare Plus, to the Board, replacing Dan Milovich
whose five-year term expired. Mr Kennedy graduated from
the University of Kansas School of Pharmacy in 1997 with a
bachelor of science degree in pharmacy. He began his career
as a staff pharmacist for Walgreens in the Phoenix, AZ, area
and has held positions as a retail pharmacy manager and
district pharmacy supervisor. Mr Kennedy is currently the
operations manager at Walgreens Central Pharmacy Operations in Tempe, AZ,
where he is responsible for Walgreens
mail order and regional retail centralization. Mr Kennedy
is also an adjunct faculty member at Midwestern College of
Pharmacy and the University ofWyoming. He is a member of
both the NationalAssociation of Drug Diversion Investigators
and Strategic National Stockpile team for Maricopa County.
Mr Kennedy resides in Gilbert, AZ, with his wife Jennifer
and their two children Gavin and Sydney. Welcome Darren
and many thanks to Mr Milovich for his five years of service.
The Board members and staff wish him well in his new home
amid the cool pines of Happy Jack, AZ.
Board staff is also pleased to announce the re-hiring of
Dennis Waggoner as the Board’s fifth compliance officer.
Some readers will remember that he previously served in
the same capacity from 2000 to 2003. Dennis returns to the
Board after a 10-year hiatus, eight years of which were spent
in drug manufacturing, an area in which he has an extensive
background. His knowledge and skills in this area were recognized when he was appointed to the Board’s Compounding
Task Force, which reviewsthe Board’s existing compounding
statutes and rulesin order to update and revise them. One goal
is to ensure that Arizona remains a modern and progressive
state that allows the proud tradition of pharmacy compounding to flourish while maintaining its history of protecting the
citizens in this state and of states where products from this
state are shipped. Coincidentally, the staff is finally back to
18 full-time employees, which was the number of employees
before the budget crunch and hiring freeze that began in 2009

quoted from Arizonia Board of Pharmacy July 2013 Newsletter

Oklahoma Board of Pharmacy Steps Up Pace on Disciplinary Action Against Compounding Pharmacies and Pharmacists Including Larry Kirkpatrick PIC and Vivien L. Grose of Red Cross Pharmacy; and Pharmacy of Pocola for fraudulent billing of compounding (2 cases 138 and 137 counts)


Disciplinary Actions
For more information, you may view hearing minutes at
www.pharmacy.ok.gov.
13.28. April 11, 2013 Board Hearing
Shannon Monteggia, Technician #17249 – Case No.
1160: Did not contest one violation of failure to obtain a
pharmacy technician permit prior to performing pharmacy
technician duties in a pharmacy. Permit placed on probation for ninety (90) days
and must attend a law seminar
in 2013. (Agreed Order)
Jason Lee O’Neal, DPh, #14970 – Case No. 1161: Did
not contest one violation of failure to supervise pharmacy
employees. Fine of $500, must attend law seminar in
addition to the required 15 hours of CE in 2013 and
2014, and all CE for 2013 and 2014 must be live. (Agreed
Order)
Ben Blackburn, DPh, #12179 – Case No. 1162: Did not
contest two violations of failure to supervise pharmacy
employees. Fine of $500, must attend law seminar
in addition to the required 15 hours of CE in 2013
and 2014, and all CE for 2013 and 2014 must be live.
(Agreed Order)
Walgreens No. 02361, #2-4841 – Case No. 1163: Did not
contest two violations including failure to maintain effective controls
against misfills and failure to supervise pharmacy employees. Fine: $6,000. (Agreed Order)
Ashley Howard, Technician #16063 – Case No. 1164:
Admitted guilt on four violations including theft of CDS
and possession of a CDS without a prescription resulting
in the loss of over 4,200 doses of CDS to the pharmacy
where she worked. Revoked. (Agreed Order)
Timothy Osborn, Technician #16150 – Case No. 1165:
Found guilty on five violations including theft of CDS
and possession of a CDS without a prescription. Revoked.
Dana Thompson, Technician #14550 – Case No. 1166:
Admitted guilt on four violations including theft of CDS
and possession of a CDS without a prescription. Revoked.
(Agreed Order)
Anthony Owens, DPh, #10513 – Case No. 1167: Admitted
guilt on five violations including failure to report disciplinary
action in another state, using an illegal CS, and
falsifying information on a pharmacist renewal. Indefinite
suspension. (Agreed Order)
Mercy Hospital Tishomingo, Inc, #61-6202 – Case No.
1168: Neither admitted nor denied guilt on three violations
including failure to be licensed, to obtain a license in a
timely manner after a change of ownership, and failure to
have a PIC. Fine: $9,000. (Agreed Order)
Wal-Mart Pharmacy No. 10-2804, #1-4460 – Case No.
1169: Neither admitted nor denied guilt on three violations
including failure to maintain effective controls against diversion
resulting in the loss of 9,788 doses of hydrocodone
products. Fine: $9,000. (Agreed Order)
Norman Regional Hospital Pharmacy, #7-523 – Case No.
1170: Admitted guilt on five violations including failure
to provide effective controls against theft and diversion
of CS and failure to maintain adequate records resulting
in the loss of over 4,200 doses of CDS. Fine: $6,000.
(Agreed Order)
13.29. May 15, 2013 Board Hearing
Doug Sisemore, DPh, #9159 – Case No. 1156: Admitted
guilt on 10 violations while acting as PIC of Reliable
Pharmacy including failure to establish and maintain effective controls
against the diversion of prescription drugs
and failing as pharmacy manager to be responsible for all
aspects of the pharmacy operation including the proper
record keeping system for drugs. Probation for five (5)
years and $10,000 fine. Must attend a law seminar in
addition to the required 15 hours of CE in 2013 and
2014 and all CE during the calendar years of 2013,
2014, and 2015 must be live CE. (Agreed Order)
Reliable Discount Pharmacy, Inc, #1-3893 – Case No.
1156: Admitted guilt on nine violations including failure
to properly maintain the required inventories and records
of CDS. Fine: $10,000. (Agreed Order)
Cindy Hudgins, Technician #13646 – Case No. 1171:
Admitted guilt on three violations including theft of CDS
and possession of a CDS without a prescription which
resulted in the loss of 1,097 doses of Schedule II CDS and
217,154 doses of Schedule III CDS to the pharmacy where
she worked. Revoked. (Agreed Order)
Sooner Pharmacy, Inc, of Tishomingo, #61-3493 – Case
No. 1172: Admitted guilt on 445 violations including
failure to provide effective controls and procedures to
guard against theft and diversion of CDS resulting in the
loss of 1,097 doses of Schedule II CDS and 217,154 doses Page 5 – July 2013
of Schedule III CDS. Probation for five (5) years and
$40,000 fine. (Agreed Order)
Michael Roy LaFevers, DPh, #9728 – Case No. 1173:
Admitted guilt on 447 violations while acting as PIC of
Sooner Pharmacy including failure as pharmacy manager
to establish and maintain effective controls and procedures
to guard against theft and diversion of CDS resulting in
the loss of 1,097 doses of Schedule II CDS and 217,154
doses of Schedule III CDS. Probation for five (5) years
and $15,000 fine. Must attend a law seminar in addition
to the required 15 hours of CE in 2013 and 2014 and
all CE must be live while on probation. (Agreed Order)
CVS/Pharmacy No. 08312, #26-5406 – Case No. 1174:
Admitted guilt on two violations including failure to keep
adequate records regarding 1,887 doses of controlled drug
substances. Fine: $3,000. (Agreed Order)
Brandon Maples, DPh, #13275 – Case No. 1175: Admitted
guilt on nine violations including administering drugs that
were not dispensed on orders from a prescribing practitioner. Indefinite suspension. (Agreed Order)
Red Cross Drug, #47-4751 – Case No. 1176: Admitted
guilt on 16 violations including failure to assign correct
beyond-use dates for sterile compounded drugs. Probation
for five (5) years and $20,000 fine. Parenteral permit is
suspended indefinitely. (Agreed Order)
Larry Kirkpatrick, DPh, #7942 – Case No. 1177: Admitted guilt on eight violations
while acting as PIC of Red Cross Drug including failure to assure compliance with
sterile compounding rules. Probation for five (5) years
and $1,000 fine. Must attend a law seminar in addition
to the required 15 hours of CE in 2013 and 2014 and
all CE must be live while on probation. (Agreed Order)
Vivien L. Grose, DPh, #11361 – Case No. 1178: Admitted
guilt on 34 violations while employed by Red Cross Drug
including failure to assign correct beyond-use dates for
sterile compounded drugs, and failure to assure compliance
with sterile compounding rules. Probation for five
(5) years and $2,000 fine. Must attend a law seminar
in addition to the required 15 hours of CE in 2013
and 2014 and all CE must be live while on probation.
(Agreed Order)
Ashley Weathers, Technician #2075 – Case No. 1179:
Admitted guilt on five violations including theft of personal
prescriptions and failure to notify the Board of address
change. Revoked. (Agreed Order)
Allen Community Pharmacy, #23-5285 – Case No. 1180:
Admitted guilt on nine violations including filling or refilling prescriptions for dangerous drugs without authorization
of a practitioner and failure to establish and maintain effective controls against the diversion of drugs. Probation
for five (5) years and $20,000 fine. (Agreed Order)
David Campbell, DPh, #12885 – Case No. 1181: Admitted guilt
on five violations
while acting as PIC of Allen
Community Pharmacy including failure to ensure that prescription
drugs are issued “by an authorized practitioner”
and failure to establish and maintain effective controls
against diversion of drugs. Probation for five (5) years
and $10,000 fine. Must attend a law seminar in addition
to the required 15 hours of CE in 2013 and 2014 and
all CE must be live while on probation. (Agreed Order)
Clay Haisten, DPh, #11522 – Case No. 1182: Admitted
guilt on 138 violations while acting as PIC of The Pharmacy of Pocola
including knowingly billing or charging
“for a brand when a generic or compounded product is
dispensed,” submitting fraudulent billing to a third-party
payer of prescription drugs, and compounding drug products
that are commercially available. Fined $15,000 and
remains on probation until October 3, 2017. Must attend a law
seminar in addition to the required 15 hours
of CE in 2013 and 2014 and all CE must be live while
on probation. (Agreed Order)
The Pharmacy of Pocola, #19-4449 – Case No. 1183:
Admitted guilt on 137 violations including submitting
fraudulent billing, and compounding drug products that
are commercially available. Probation for five (5) years
and $15,000 fine. (Agreed Order)

quoted from Oklahoma Board of Pharmacy July 2013 Newsletter


Oklahoma Board of Pharmacy Rules Regarding Compounding Inhalant Solutions:


13.26. Inhalant Solutions: Inhalant solutions are considered to be sterile drug products and must be compounded as such under applicable sterile compounding regulations
and rules. All compounders should closely review and be
very familiar with the compounding rules that apply to
their pharmacy practice.

quoted from Oklahoma Board of Pharmacy July 2013 Newsletter

Oklahoma Board of Pharmacy Rules Regarding Sale of Prescription Medication to an Outof-State Patient or Entity


13.24. Sale of Prescription Medication to an Outof-State Patient or Entity:
Pharmacies may not sell prescription drugs to wholesalers (returning a product
that was purchased from a wholesaler to the wholesaler
for credit is considered a “return,” not a “sale”). The sale
of any prescription medication to an out-of-state patient
or entity almost always requires that the pharmacy be
licensed with the state into which they are shipping. State
boards are actively prosecuting those in violation of this
regulation.

quoted from Oklahoma Board of Pharmacy July 2013 Newletter

Oklahoma Board of Pharmacy Rules Regarding Hospitals and Non-Patient-Specific Compounded Medications

13.23. Hospitals and Non-Patient-Specific Compounded Medications:
Hospitals that purchase non-patient specific compounded medications
must confirm that the state in which the compounding pharmacy resides
allows non-patient-specific compounded medications to be sold
by the compounding pharmacy. Most states do not allow
this practice.

quoted from Oklahoma Board of Pharmacy July 2013 Newsletter

Thousands of Rogue Online Drug Sellers Shut Down During Operation Pangea VI July 3, 2013 1:50 pm

As part of the sixth annual International Internet Week of Action (IIWA), Food and Drug Administration (FDA) took action against more than 9,600 Web sites illegally selling drugs that included counterfeit, substandard, and other potentially dangerous products. FDA seized and shut down 1,677 of the Web sites, and issued regulatory warnings to others. FDA reports that many of the Web sites that were shut down “appeared to be operating as a part of an organized criminal network that falsely purported its websites to be ‘Canadian Pharmacies.’” FDA notes that the Web sites displayed fake licenses and certifications, advertised brand name drugs, and claimed that drug products were FDA approved. Investigations during the course of Operation Pangea VI, part of the IIWA efforts, revealed that the products were not from Canada, were not brand-name products, and were not FDA approved. Operation Pangea VI brought together law enforcement, customs, and regulatory authorities from 99 countries “to identify the makers and distributors of illegal drug products and medical devices and remove these products from the supply chain,” indicates an FDA news release. IIWA is a collaborative effort involving FDA, INTERPOL, the World Customs Organization, Heads of Medicines Agencies Working Group of Enforcement Officers, and health and law enforcement agencies from the 99 participating countries. Worldwide, the efforts resulted in 58 arrests and “the seizure of 9.8 million potentially dangerous medicines,” reports INTERPOL. Private entities also aided in the IIWA effort, and LegitScript, an Internet pharmacy monitoring organization, contributed to the closure of 6,700 rogue online drug sellers, reports The Wall Street Journal.
quoted from National Association of Boards of Pharmacy

American Nurse Today

American Nurse Today

Nevada Board of Pharmacy Pharmacy Compounding Update--Kudos for the State's Actions


Pharmacy Compounding Update
In an effort to keep you in the loop regarding the
national tragedy that has unfolded as a result of contaminated products compounded by New England
Compounding Center (NECC) and concerns about their
sister company (Ameridose), the Nevada State Board of
Pharmacy offers the following:
♦ Both pharmacies were licensed in Nevada as “outof-state pharmacies,” however, the Board did not
renew either license in October 2012.
♦ In conjunction with the Nevada Department of
Health and Human Services, all pharmacies, surgery centers, hospitals, and clinics were notified
of the  NECC recall of all of their products, and a
notification was sent to all consulting pharmacists.
NECC was contacted to obtain a list of buyers in
Nevada as a double check. A small number of NECC
compounded products were indeed found in a Las
Vegas, NV, surgery center; however, none were
used, thankfully, and those vials were confiscated.
♦ The Board then pulled all of its investigative and
inspection staff members off their regular duties
and conducted inspections of all Nevada pharmacies
that compound sterile products.
These inspections included sterility and strength
testing of randomly selected products from each
pharmacy.
Board staff accompanied Food and Drug Administration (FDA) inspectors (out of the San
Francisco Bay-area regional office) and Nevada
Department of Health and Human Services inspectors in conducting one Nevada pharmacy
inspection.
♦ Note: The Board enacted comprehensive compounding regulations in 2008; has trained its entire inspecting and investigatory staff in sterile compounding;
and inspects, at least annually, according to those
regulations.
♦ Committees in both the United States Senate and
the US House of Representatives have held hearings
to analyze the NECC issue and to consider regulatory changes to pharmacy compounding to ensure
prevention of another such incident.
♦ Board Executive Secretary Larry Pinson attended
a meeting called by FDA on December 19, 2012,
at FDA Headquarters in Maryland, to explore compounding pharmacy and its oversight.
♦ The National Association of Boards of Pharmacy®
has developed a Compounding Action Plan in a
national effort for better oversight of compounding
pharmacies.
The Board reminds all pharmacists that pharmacies
are licensed by boards of pharmacy to fill prescriptions,
not to manufacture drugs. FDA licenses manufacturers
to manufacture drugs. Purchases of drugs should only be
made from Nevada-licensed, FDA-approved manufacturers or wholesalers. NECC was not licensed or overseen
by FDA, yet they were clearly manufacturing, and the
results are obvious and tragic.

quoted from Nevada  Board of Pharmacy July 2013 Newsletter

Wednesday, July 3, 2013

Medscape Ophthalmology The Compounding Controversy Laura A. Stokowski, RN, MSDisclosures Jul 03, 2013

The Compounding Pharmacy: From Humble Roots

We have come a long way from the traditional compounding pharmacy, which dates back hundreds of years. Picture the village apothecary, bending over his mortar and pestle by the light of an oil lamp to prepare a special elixir or poultice for a sick patient. Their successors, pharmacists, might have more ingredients, tools, and instruments, but they serve the same valuable role as a local source of drugs, prepared in doses or formulations that are not commercially available to treating clinicians (Figure).

Continue to read here

Indiana Board of Pharmacy July 8, 2013 Agenda

View here. Look at the number of out-of-state compounding pharmacies seeking license.

Pharmacy Times Grows Strategic Alliance Program with New Industry Partners


The pharmacy industry’s No. 1 journal, Pharmacy Times, and its sister publication, Specialty Pharmacy Times, continue to add new industry-leading companies and organizations to their Strategic Alliance Partnership (SAP) programs.
The Strategic Alliance Partnership programs facilitate collaboration and the exchange of knowledge among partners and ultimately increase their visibility within the pharmacy industry. Pharmacy Times has more than 60 established partnerships; Specialty Pharmacy Times has nearly 30.
Pharmacy Times’ newest SAP members are:
  •  Roundy’s Inc. (NYSE: RNDY) 5 grocery banners with 161 stores and 100 pharmacies across 3 states:
    • Copps has 25 conventional grocery stores located in the Madison, WI area as well as in certain northern Wisconsin markets, including Green Bay and Appleton.

    • Continue reading here.

Next Georgia Board of Pharmacy Meeting July 17, 2013


Georgia Board of Pharmacy Adopts New Emergency Rule Regarding Synthetic Cannabinoids


Notice of Adoption of Emergency Rule

July 2, 2013
NOTICE OF ADOPTION OF EMERGENCY RULE; REASONS FOR ADOPTING OF AN EMERGENCY RULE TO THE GEORGIA STATE BOARD OF PHARMACY RULES CHAPTER 480-34, RULE 480-34-0.13-.09 ADDITIONAL SYNTHETIC CANNABINOIDS
TO ALL INTERESTED PERSONS AND PARTIES:
Notice is hereby given that pursuant to the authority set forth below, the Georgia State Board of Pharmacy (hereinafter “Board”) is adopting an emergency rule to the Georgia Board of Pharmacy Rules, Chapter 480-34, Rule 480-38-0.13-09 (hereinafter “emergency rule”).
This emergency rule will be adopted under the authority of O.C.G.A. § 50-13-4 (b). This rule will be adopted to protect the health, safety, and/or welfare of the citizens of the State of Georgia. Under O.C.G.A. § 50-13-4 (b), a board may proceed to adopt a rule with less than thirty (30) days of notice, with such rule being effective for no longer than one hundred and twenty (120) days, so long as the reasons for the aforementioned rule are stated in writing. 
This emergency rule classifies additional newly discovered compounds of synthetic cannabinoids as Schedule I substances under the Georgia Controlled Substances Act (O.C.G.A. § 16-13-25(12)). 
The stated reason for the adoption of this rule is as follows:
The Georgia Bureau of Investigation has determined that synthetic cannabinoids is now appearing throughout Georgia at an increased level.  Documented Poison Center reports show that users of synthetic cannabinoids can experience symptoms that include, but are not limited to, the following: altered mental status, lethargy, short-term coma, seizures, and psychosis.
Previously, during the 2010 Legislative Session, the Legislature banned all forms of synthetic cannabinoids as Schedule I substances in the State of Georgia. However, manufacturers altered their formulas to bypass the effectiveness of the law.  During the 2012 Legislative Session, the Legislature revisited this issue and passed a more inclusive law, SB 370 (“Chase’s Law”), which covered all variations of the chemical compounds within the synthetic cannabinoid products. However, manufacturers have now begun changing the molecular structure of the drug altogether in order to circumvent the current law. 
The Georgia Bureau of Investigation has determined that synthetic cannabinoids manufactured using these new molecular structures have begun appearing in Georgia.  Since the adoption of Emergency Rules on or about June 11, 2012, June 27, 2012 and August 15, 2012, August 27, 2012 and a permanent rule on October 10, 2012 addressing certain new molecular structures as synthetic cannabinoids, the Georgia Bureau of Investigation has identified some additional molecular structures that are being manufactured to circumvent the current law.
In order to protect the general health, safety, and welfare of the citizens of the State of Georgia, an emergency rule is being adopted to immediately classify these new additional molecular structures as Class I substances under the Georgia Controlled Substances Act. 
The proposed emergency rule will be considered for adoption by the Georgia State Board of Pharmacy at a conference call scheduled to begin at 2:00 p.m. on July 3, 2013, at the Department of Community Health at 2 Peachtree Street, NW., Atlanta, Georgia 30303. According to the Department of Law, State of Georgia, the Georgia State Board of Pharmacy has the authority to adopt the proposed rules pursuant to authority contained in O.C.G.A Secs. 16-13-22, 26-4-28, and 50-13-4. 
This notice, together with an exact copy of the adopted emergency rule and a synopsis of the emergency rule, is being forwarded to all persons and/or parties who have requested in writing that they be placed on the interested parties list.  A copy of this notice, an exact copy of the emergency rule, and a synopsis of the emergency rule may be reviewed during normal business hours (8:00 a.m. to 5:00 p.m., Monday- Friday, with the exception of State Holidays) at the Department of Community Health.  Copies may also be requested by contacting the Board office at (404) 651-8000.
For further information, please contact the Board office at (404) 651-8000.
This notice is given in compliance with O.C.G.A. § 50-13-4 (b) of the Georgia Administrative Procedures Act.
This 2nd Day of July, 2013
TANJA D. BATTLE
Executive Director
Georgia Board of Pharmacy
POSTED:  July 2, 2013

Next Hawaii Board of Pharmacy Meeting July 18, 2013


Illinois Board of Pharmacy Meeting July 9, 2013 Agenda

can be viewed here

Next Iowa Board of Pharmacy Meeting July 16-17, 2013


North Carolina Board of Pharmacy Meeting to be Held July 9, 2013


http://www.nodakpharmacy.com/pdfs/may2013.pdf

can be viewed here

Next Idaho Board of Pharmacy Meeting July 29, 2013


Date: July 29, 2013
Location: Conference Call
Room: Conference Room
Time(MST): 8:00 am to 10:00 am
Agenda (currently not available)
Agenda Packet - Board Member Access Only (currently not available)

Next Kentucky Board of Pharmacy Meeting July 10, 2013


Minnesota Board of Pharmacy May 2013 Board Minutes

can be viewed here

Next Minnesota Board Meeting is Tuesday, July 30, 2013 (cutoff is 7/15/13)


Next Mississippi Board of Pharmacy Meeting July 25, 2013


Missouri Board of Pharmacy June 2013 Patient Safety Newsletter

can be viewed here

Complete list of Pharmacies and Pharmacists Disciplined in Missouri since 2007

can be found here

Missouri Board of Pharmacy Meeting Scheduled for July 17, 2013


Three Montana Board of Pharmacy Meetings with Agenda's for July 2013


Current Meetings: (Occurring 60 Days)

Meeting: Full Board
Detail: In Person Meeting
Date: 7/12/2013
Location: Park Avenue Building, 301 S Park, 4th Floor Large Conference Room, Helena MT

Public Access: Open
View: Agenda
Meeting: Screening
Detail: In Person Meeting
Date: 7/11/2013
Location: Park Ave Blgd 301 South Park Ave 4th Floor Large Conference Room #430 Helena Montana

Public Access: Closed
View: Agenda
Meeting: Sub-Committee
Detail: N/A
Date: 7/9/2013
Location: 301 S Park Avenue, 4th Floor, Helena, MT

Public Access: Open
View: Agenda

Next Nebraska Board of Pharmacy Meeting 7/15/13 ​8:30 a.m. ​Country Inn & Suites 5353 N 27th St Lincoln, NE


Rhode Island Board of Pharmacy Meeting July 03, 2013